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CELESTONE

NDA

BETAMETHASONE | N014215 | MERCK SHARP AND DOHME CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain13 active DMFs23 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

HOVIONE FARMACIENCIA SABETAMETHASONE 21-ACETATE

DMF 67131986

TARO PHARMACEUTICAL INDUSTRIES LTDBETAMETHASONE 17-VALERATE, USP MICRONIZED

DMF 150042000

TAPI NL BVBETAMETHASONE ACETATE

DMF 153272001

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBETAMETHASONE USP

DMF 170162003

HIKMA PHARMACEUTICALS LLCBETAMETHASONE ACETATE (STERILE) USP

DMF 181262005

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE VALERATE, USP (MICRONIZED)

DMF 220622008

MAHIMA LIFE SCIENCES PRIVATE LTDBETAMETHASONE USP

DMF 278902013

GLAND PHARMA LTDBETAMETHASONE ACETATE USP STERILE

DMF 307162016

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBETAMETHASONE USP BULK API

DMF 338932019

AURISCO PHARMACEUTICAL CO LTDBETAMETHASONE

DMF 357392021

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE ACETATE USP

DMF 360862022

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDBETAMETHASONE

DMF 370532022

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE

DMF 397092024

ANTIBIOTICOS SPAInactiveBETAMETHASONE SODIUM PHOSPHATE, N.F. XIII BULK

DMF 23771974

ANTIBIOTICOS SPAInactiveBETAMETHASONE 17-VALERATE, NF BULK, NON STERILE, NON MICRON & MICRON

DMF 31051978

PARKE DAVIS DIV WARNER LAMBERT COInactiveBETAMETHASONE 17-BENZOATE MNFG BY VISTER S.P.A.(ITALY)(FACIL.OF PD/WL

DMF 39801980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE BASE USP XX

DMF 40041980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveBETAMETHASONE NA PHOSPHATE

DMF 42941981

SCHERING PHARMACEUTICAL CORPInactiveBETAMETHASONE USP

DMF 43171981

HOVIONE FARMACIENCIA SAInactiveBETAMETHASONE 17-VALERATE

DMF 43971981

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveBETAMETHASONE ACETATE

DMF 47071982

HOVIONE FARMACIENCIA SAInactiveBETAMETHASONE 17,21-DIPROPIONATE

DMF 52741984

NITA PHARMACEUTICAL LTDInactiveBETAMETHASONE AND BETAMETHASONE SALTS

DMF 54311984

SCHERING AGInactiveBETAMETHASONE

DMF 58341985

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveBETAMETHASONE

DMF 60181985

DIOSYNTH BVInactiveBETAMETHASONE ACETATE

DMF 60201985

DIOSYNTH BVInactiveBETAMETHASONE MICRO

DMF 68251987

FARMABOISInactiveBETAMETHASONE 17 VALERATE

DMF 69601987

FARMABOISInactiveBETAMETHASONE

DMF 69611987

FARMABOISInactiveBETAMETHASONE 17,21 DIPROPIONATE

DMF 70361987

QUATRUMInactiveBETAMETHASONE BASE

DMF 70381987

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE ACETATE

DMF 72691987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE

DMF 75561988

DIOSYNTH BVInactiveBETAMETHASONE DIPRIONATE

DMF 76671988

ROUSSELL UCLAFInactiveBETAMETHASONE ACETATE

DMF 77161988

NEWCHEM SPAInactiveBETAMETHASONE 17-VALERATE MICRONIZED

DMF 224062009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 21, 2006	SUPPL -9	View Letter (PDF)
Jul 21, 2006	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.6MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.